Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Adcetris (Brentuximab Vedotin), kombinovaná chemoterapie a radiační terapie při léčbě mladších pacientů s Hodgkinovým lymfomem stadia IIB, IIIB a IV

11. listopadu 2026 aktualizováno: St. Jude Children's Research Hospital

Adcetris (Brentuximab Vedotin), náhražka vinkristinu v režimu OEPA/COPDac [Léčebná skupina 3 (TG3) Euro-Net C1] se zapojenou radiační terapií uzlin u vysoce rizikového dětského Hodgkinova lymfomu (HL)

This pilot phase II trial studies how well giving brentuximab vedotin, combination chemotherapy, and radiation therapy works in treating younger patients with stage IIB, IIIB or IV Hodgkin lymphoma. Monoclonal antibodies, such as brentuximab vedotin, can block cancer growth in different ways. Some block the ability of cancer to grow and spread. Others find cancer cells and help kill them or carry cancer killing substances to them. Drugs used in chemotherapy, such as etoposide, prednisone, doxorubicin hydrochloride, cyclophosphamide, and dacarbazine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill cancer cells. Giving brentuximab vedotin with combination chemotherapy may kill more cancer cells and reduce the need for radiation therapy.

Přehled studie

Postavení

Aktivní, ne nábor

Podmínky

Intervence / Léčba

Detailní popis

PRIMARY OBJECTIVES:

To evaluate the safety of brentuximab vedotin, etoposide, prednisone and doxorubicin hydrochloride (AEPA)/cyclophosphamide, brentuximab vedotin, prednisone and dacarbazine (CAPDac), as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high risk patients with Hodgkin lymphoma (HL).
To compare the event-free survival in high risk HL patients treated with AEPA/CAPDac to the historical control unfavorable risk 2 arm (UR2) of the St. Jude HOD99 study.

SECONDARY OBJECTIVES:

To estimate the number of patients with adequate response according to the definitions in the Euro-Net C1 after 2 cycles of AEPA.
To evaluate the safety of Adcetris (brentuximab vedotin) in the AEPA/CAPDac regimen in children with high risk HL.
To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
To study the association between local failure and original lymph node region and volume of radiation (patterns of treatment failure).
To assess patient-reported symptoms and health-related quality of life in children with high risk HL compared to those treated on the unfavorable treatment arm of the St. Jude HOD99 study.

OUTLINE:

AEPA REGIMEN: Patients receive brentuximab vedotin on days 1, 8, and 15, etoposide on days 1 to 5, prednisone three times daily (TID) on days 1 to 15, and doxorubicin hydrochloride on days 1 and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.

CAPDac REGIMEN: Patients receive cyclophosphamide on days 1 and 8, brentuximab vedotin days 1 and 8, prednisone TID on days 1 to 15, and dacarbazine on days 1 to 3. Treatment repeats every 21-28 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Beginning 2-3 weeks after CAPDac chemotherapy, patients with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy undergo radiation therapy daily, 5 days a week for 3-4 weeks.

After completion of study treatment, patients are followed up every 3 months for 1 year, every 4 months for 2 years, every 6 months for 2 years, and then annually for 5 years.

Typ studie

Intervenční

Zápis (Aktuální)

Fáze

Fáze 2

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

Spojené státy
- California
  - Palo Alto, California, Spojené státy, 94304
    - Lucile Packard Children's Hospital Stanford University
- Illinois
  - Peoria, Illinois, Spojené státy, 61637
    - St. Jude Midwest Affiliate
- Maine
  - Scarborough, Maine, Spojené státy, 04704
    - Maine Children's Cancer Program (MCCP)
- Massachusetts
  - Boston, Massachusetts, Spojené státy, 02114
    - Massachusetts General Hospital Cancer Center
  - Boston, Massachusetts, Spojené státy, 02115
    - Dana-Farber Harvard Cancer Center
- Tennessee
  - Memphis, Tennessee, Spojené státy, 38105
    - St. Jude Children's Research Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

Ne starší než 18 let (Dítě, Dospělý)

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

Histologically confirmed, previously untreated CD30+ classical Hodgkin Lymphoma (HL). (Participants receiving limited emergent radiation therapy (RT) or steroid therapy - maximum of 7 days - because of cardiopulmonary decompensation or spinal cord compression will be eligible for protocol enrollment).
Age ≤ 18 years at the time of diagnosis (i.e., participants are eligible until their 19th birthday).
Ann Arbor stage IIB, IIIB, IVA, or IVB.
Adequate renal function based on GFR ≥ 70 ml/min/1.73m^2 or serum creatinine adjusted for age and gender.
Adequate hepatic function (total bilirubin < 1.5 x ULN for age, and SGOT/SGPT < 2.5 x ULN for age).
Female participant who is post-menarchal must have a negative urine or serum pregnancy test.
Female or male participant of reproductive potential must agree to use an effective contraceptive method throughout duration of study treatment.

Exclusion Criteria:

CD30 negative HL.
Has received prior therapy for Hodgkin lymphoma, except as noted above.
Inadequate organ function as described above.
Inability or unwillingness of research participant or legal guardian / representative to give written informed consent.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Primární účel: Léčba
Přidělení: N/A
Intervenční model: Přiřazení jedné skupiny
Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm Skupina účastníků / Arm Skupina nebo podskupina účastníků klinické studie, která podle protokolu studie dostává konkrétní intervenci/léčbu nebo žádnou intervenci.	Intervence / Léčba Intervence / Léčba Proces nebo akce, na které se klinická studie zaměřuje. Intervence zahrnují léky, zdravotnická zařízení, postupy, vakcíny a další produkty, které jsou buď zkoušené nebo již dostupné. Intervence mohou také zahrnovat neinvazivní přístupy, jako je edukace nebo úprava stravy a cvičení.
Experimentální: Treatment Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.	Lék: brentuximab vedotin Given intravenously (IV). Ostatní jména: SGN-35 Adcetris(R) Lék: etoposide Given IV. Ostatní jména: VP-16 Vepesid(R) Lék: prednisone Given orally (PO). Ostatní jména: prednisolon Lék: doxorubicin Given IV. Ostatní jména: Adriamycin(R) Lék: cyclophosphamide Given IV. Ostatní jména: Cytoxan(R) Lék: Dacarbazine(R) Given IV. Ostatní jména: Dimethyl Triazeno Imidazol Karboximid (DTIC) Lék: filgrastim Given subcutaneously (SQ) as clinically indicated. Ostatní jména: Neupogen(R) Jiný: quality of life assessment Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant. Záření: radiation therapy At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission. Ostatní jména: ozáření záření radioterapie

Skupina účastníků / Arm

Intervence / Léčba

Experimentální: Treatment

Participants receive AEPA regimen (brentuximab vedotin, etoposide, prednisone, doxorubicin), and CAPDac regimen (cyclophosphamide, brentuximab vedotin, prednisone, dacarbazine(R)). Filgrastim may be given as clinically indicated. For those with lymph nodes that do not go into remission after 2 courses of AEPA chemotherapy, radiation therapy will be given. Some participants may volunteer to complete the quality of life assessment.

Lék: brentuximab vedotin

Given intravenously (IV).

Ostatní jména:

SGN-35
Adcetris(R)

Lék: etoposide

Given IV.

Ostatní jména:

VP-16
Vepesid(R)

Lék: prednisone

Given orally (PO).

Ostatní jména:

prednisolon

Lék: doxorubicin

Given IV.

Ostatní jména:

Adriamycin(R)

Lék: cyclophosphamide

Given IV.

Ostatní jména:

Cytoxan(R)

Lék: Dacarbazine(R)

Given IV.

Ostatní jména:

Dimethyl Triazeno Imidazol Karboximid (DTIC)

Lék: filgrastim

Given subcutaneously (SQ) as clinically indicated.

Ostatní jména:

Neupogen(R)

Jiný: quality of life assessment

Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.

Záření: radiation therapy

At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.

Ostatní jména:

ozáření
záření
radioterapie

Co je měření studie?

Primární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control Časové okno: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)	To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 (NCT00145600) unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.	After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Percentage of Initially Enrolled Patients That Have a Complete Response at Early Response Assessment Compared to Historical Control Časové okno: After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)	To determine the efficacy of 2 cycles of AEPA chemotherapy, the response rate for the first 32 evaluable participants enrolled was evaluated. If it shown efficacy (detect 20% increase complete rate with 80% power and 5% type I error compared with the proportion of historical control of HOD99 unfavorable risk patients had complete rate at week 8 of 17% (24/141), the response results will be reported in a national/international meeting and the study will continue to enroll for a total of 77 patients.	After the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Complete Response Rate Estimate for All Evaluable Participants Časové okno: After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)	To evaluate the safety of AEPA/CAPDac, as well as the efficacy (early complete response) after 2 cycles of AEPA chemotherapy in high-risk patients with Hodgkin Lymphoma (HL).	After the first 2 cycles of chemotherapy (at 2 months from enrollment for each participant)
Comparison of the Event-free (EFS) Survival in High Risk HL Patients Treated With AEPA/CAPDac to the Historical Control HOD99 Unfavorable Risk 2 Arm (UR2). Časové okno: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)	Event-free survival (EFS) is defined as the probability of survival between the date of study enrollment to the date of first event (relapsed or progressive disease, second malignancy, or death from any cause) or to last follow-up for patients without events. Under the proportional hazard model assumption, the two-sample log-rank test used to compare the EFS between HLHR13 and historical control of HOD99 unfavorable risk 2 arm (UR2).	From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)

Sekundární výstupní opatření

Měření výsledku	Popis opatření	Časové okno
Local Failure Rate in High Risk HL Patients Treated With AEPA/CAPDac. Časové okno: From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)	The local failure rate within the high-risk HL participants treated with AEPA/CAPDac will be estimated with a 95% confidence interval using appropriate methods (e.g., estimate cumulative incidence in the presence of competing risks).	From start of therapy to 2 years after completion of therapy (up to 3 years after study enrollment)
Descriptive of Hematological Adverse Events Časové okno: From enrollment to end of therapy (approximately 8 months)	To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From enrollment to end of therapy (approximately 8 months)
Descriptive of Infectious Adverse Events Časové okno: From enrollment to end of therapy (approximately 8 months)	To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From enrollment to end of therapy (approximately 8 months)
Descriptive of Neuropathic Adverse Events Časové okno: From enrollment to end of therapy (approximately 8 months)	To describe acute hematologic, neuropathic, and infectious toxicities as they relate to transfusion requirements, growth factor support, episodes of febrile neutropenia and hospitalizations, according to the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.	From enrollment to end of therapy (approximately 8 months)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.3.0) Časové okno: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)	Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 3. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
To Assess the Patient Reported Symptoms and Health-related Quality of Life in Children With High Risk HL Compared to Those Treated on the Unfavorable HOD99 Treatment Arm (UR2) at Multiple Time Points. (PedsQL v.4.0) Časové okno: At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)	Assess and compare the patient reported quality of life and symptom distress to that of patients treated on the HOD99 unfavorable risk 2 arm (UR2) using the Peds Quality of Life version 4. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At Diagnosis (baseline) (T1), completion of 2 cycles of chemotherapy (approximately 2 months) (T2), completion of 4 cycles of chemotherapy (approximately 4 months) (T3), completion of radiation (approximately 8 months) (T4)
Response Rate Časové okno: after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)	Response compared to the Euro-Net C1 after 2 cycles of AEPA.	after the first 2 cycles of chemotherapy (at approximately 2 months after enrollment)
Patient Quality of Life (QoL) Časové okno: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).	Patient QOL will be measured at multiple time points to assess the patient's physical emotional, social, and school functioning. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment).
Parent Proxy Quality of Life (QoL) Časové okno: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)	Parent's assessment of child's physical, emotional, social and school functioning over multiple time points. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)
Correlation of Agreement Between Patient QoL and Parent Proxy QoL at Multiple Time Points Časové okno: At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)	The correlation of agreement between patient and parent Quality of Life is calculated by using the Pearson's Correlation Coefficient, which considers only the record with both parent and patient data. The QL scoring is a 5-point Likert scale from 0 (never) to 4 (almost always). Scores are transformed on a scale from 0 to 100. Items are reverse scored and linearly transformed to a 0-100 scale as follows: 0=100, 1=75, 2=50, 3=25, and 4=0. Total score is the sum of all items over the number of items answered on all scales. For both the total score and subscales the range is 0-100. The total score is the sum of all items from each subscale, over the number of items answered on the scale. The total score is the sum of all items on the scale over the number of items answer. If >50% of the items are missing the score should not be computed. If >50% are completed, impute the mean of the completed items in a scale. The Higher the score the better quality of life.	At various time points from diagnosis through 5 years off therapy. (up to approximately 6 years from enrollment)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

St. Jude Children's Research Hospital

Spolupracovníci

Seagen Inc.

Vyšetřovatelé

Vrchní vyšetřovatel: Matt Ehrhardt, MD, St. Jude Children's Research Hospital

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

12. srpna 2013

Primární dokončení (Aktuální)

16. listopadu 2020

Dokončení studie (Odhadovaný)

1. května 2028

Termíny zápisu do studia

První předloženo

6. srpna 2013

První předloženo, které splnilo kritéria kontroly kvality

8. srpna 2013

První zveřejněno (Odhadovaný)

12. srpna 2013

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

11. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

HLHR13
NCI-2013-01123 (Identifikátor registru: NCI Clinical Trial Registration Program)

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ano

Studuje produkt zařízení regulovaný americkým úřadem FDA

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Adcetris (Brentuximab Vedotin), kombinovaná chemoterapie a radiační terapie při léčbě mladších pacientů s Hodgkinovým lymfomem stadia IIB, IIIB a IV

Adcetris (Brentuximab Vedotin), náhražka vinkristinu v režimu OEPA/COPDac [Léčebná skupina 3 (TG3) Euro-Net C1] se zapojenou radiační terapií uzlin u vysoce rizikového dětského Hodgkinova lymfomu (HL)

Přehled studie

Postavení

Podmínky

Intervence / Léčba

Detailní popis

Typ studie

Zápis (Aktuální)

Fáze

Kontakty a umístění

Studijní místa

Kritéria účasti

Kritéria způsobilosti

Věk způsobilý ke studiu

Přijímá zdravé dobrovolníky

Pohlaví způsobilá ke studiu

Popis

Studijní plán

Jak je studie koncipována?

Detaily designu

Počet zbraní

Zbraně a zásahy

Skupina účastníků / Arm

Intervence / Léčba

Co je měření studie?

Primární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Sekundární výstupní opatření

Měření výsledku

Popis opatření

Časové okno

Spolupracovníci a vyšetřovatelé

Sponzor

Spolupracovníci

Vyšetřovatelé

Publikace a užitečné odkazy

Obecné publikace

Užitečné odkazy

Termíny studijních záznamů

Hlavní termíny studia

Začátek studia (Aktuální)

Primární dokončení (Aktuální)

Dokončení studie (Odhadovaný)

Termíny zápisu do studia

První předloženo

První předloženo, které splnilo kritéria kontroly kvality

První zveřejněno (Odhadovaný)

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

Naposledy ověřeno

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Studuje produkt zařízení regulovaný americkým úřadem FDA